Injection of a therapeutic formulation into a wall of the gastrointestinal tract
A device includes an inflatable balloon, a reservoir disposed within the inflatable balloon, a needle compartment attached to the balloon and to the reservoir, an injection needle disposed within the needle compartment, and an inflation mechanism. The reservoir contains a therapeutic preparation. The inflation mechanism is structured to inflate the balloon, and upon inflation, the injection needle is structured to enter the reservoir. A method includes making an autoinjector available to a subject with instructions to ingest the autoinjector. The autoinjector is structured to inject a therapeutic preparation into a wall of a gastrointestinal tract of the subject responsive to ingestion of the autoinjector. The autoinjector includes an injection needle disposed in a needle compartment attached to a reservoir. The injection needle is initially separated from the reservoir, and is structured to enter the reservoir for delivery of the fluid therapeutic preparation through the needle into the wall.
1 . A swallowable autoinjector device, comprising:
an inflatable balloon;
a reservoir disposed within the inflatable balloon, the reservoir containing a fluid therapeutic preparation comprising a therapeutic agent;
a needle compartment attached to the balloon and to the reservoir;
an injection needle disposed within the needle compartment; and
an inflation mechanism structured to inflate the balloon, wherein the injection needle is structured to enter the reservoir at a proximal end of the injection needle upon inflation of the balloon.
2 . The device of claim 1 , wherein the reservoir is structured to contain up to 0.5 cubic centimeters of fluid.
3 . The device of claim 2 , wherein the reservoir contains 0.5 cubic centimeters of fluid.
4 . The device of claim 1 , wherein the device is structured to contain up to 50 milligrams of the therapeutic agent.
5 . The device of claim 1 , wherein the therapeutic agent comprises two or more different therapeutic agents included in the therapeutic preparation.
6 . The device of claim 1 , wherein the inflation mechanism comprises a first reactant and a second reactant, and the inflation mechanism is structured to keep the first and second reactants separate from each other until after the device encounters a fluidic environment, wherein the first reactant and second reactant are selected to react with each other to cause a gas to form and thereby inflate the balloon.
7 . The device of claim 6 , further comprising a pouch contained within an inner volume of the balloon, the pouch containing the first reactant and being in fluid communication with a conduit, the conduit being in fluid communication with both an inside volume of the pouch and an inner volume of the balloon containing the second reactant, and a release valve disposed between the pouch and the conduit, the release valve being configured to degrade upon contact with a fluidic environment.
8 . The device of claim 6 , wherein the reservoir comprises a membrane configured to be compressed by the gas generated by reaction of the first and second reactants and thereby cause the fluid therapeutic preparation to flow from the reservoir into the injection needle.
9 . The device of claim 1 , wherein the device is structured to deliver the therapeutic preparation through a wall of the gastrointestinal tract or through the wall and into the peritoneal cavity.
10 . The device of claim 1 , further comprising a deflation valve configured to deflate the balloon after the fluid therapeutic composition has been expelled from the reservoir.
11 . The device of claim 10 , wherein the deflation valve is covered with a flap when the balloon is in a non-inflated state.
12 . The device of claim 1 , further comprising a sizing member configured to contact a portion of a gastrointestinal tract wall and urge an opposing side of the balloon against another portion of the gastrointestinal tract wall.
13 . The device of claim 1 , wherein the needle compartment comprises an upper chamber and a lower chamber, the upper chamber including a collar and a collapsible tube configured to protect and support the injection needle, wherein the collar is at least partially formed of a material that degrades upon exposure to a fluidic environment.
14 . The device of claim 1 , wherein the injection needle has a tubular shape with a central channel extending between a distal end and the proximal end, wherein the distal end terminates at a sharp tip.
15 . The device of claim 1 , wherein the injection needle comprises biodegradable material.
16 . The device of claim 1 , further comprising a fill port coupled to the reservoir.
17 . The device of claim 1 , wherein the device is contained within a capsule that degrades within the gastrointestinal tract.
18 . The device of claim 1 , wherein the therapeutic agent comprises one or more selected from antibodies, growth hormones, parathyroid hormones, interferons, immuno-chemotherapeutic agents, antibiotics, antivirals, insulin and related compounds, glucagon-like peptides, anti-seizure agents, anti-migraine medications, immune suppression agents, and anti-parasitic agents.
19 . A method of manufacturing the swallowable autoinjector device of claim 1 , the method comprising:
providing the needle compartment and the reservoir;
sealing one end of the needle compartment;
disposing the needle compartment partially within the reservoir;
disposing the injection needle in a cavity defined by the needle compartment, wherein the injection needle is structured to enter the reservoir at a proximal end of the injection needle; and
adding to the reservoir the fluid therapeutic preparation.
20 . The method of claim 19 , further comprising disposing the reservoir containing the fluid therapeutic preparation and the needle compartment containing the injection needle within the inflatable balloon.
21 . A method of administering a therapeutic agent to a subject in need thereof, comprising orally administering a capsule containing the device of claim 1 .